Post Diabetes Prevention Program Follow-up Study

糖尿病预防计划后续研究

基本信息

批准号：
7189340
负责人：
Ronald B Goldberg
金额：
$ 26.96万
依托单位：
UNIVERSITY OF MIAMI SCHOOL OF MEDICINE
依托单位国家：
美国
项目类别：
财政年份：
1994
资助国家：
美国
起止时间：
1994-08-20 至 2009-01-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7189340
关键词：
2,4-thiazolidinedione Accounting Address Adopted Adult Advisory Committees Affect African African American Age Age-Years Aging Air Albumins American Ankle Anthropometry Antioxidants Anxiety Appearance Appendix Arterial Fatty Streak Asians Asorbicap Atherosclerosis Autopsy Behavior Therapy Behavioral Beta Cell Biochemical Biochemistry Blood Glucose Blood Pressure Body Weight decreased Budgets Calendar Caliber Cardiovascular Diseases Cardiovascular system Categories Cations Caucasians Caucasoid Race Cell physiology Centers for Disease Control and Prevention (U.S.)Characteristics Cholesterol Chronic Chronic Disease Cities Classification Clinical Clinical Research Clinical Trials Closure Cohort Effect Collaborations Collection Combined Modality Therapy Complication Complications of Diabetes Mellitus Conceptions Condition Consensus Control Groups Controlled Clinical Trials Controlled Study Coronary Coronary Arteriosclerosis Costs and Benefits Cox Models Creatinine Cross-Sectional Studies Cystatins Data Data Analyses Development Diabetes Mellitus Diabetes prevention Diabetic Angiopathies Diabetic Microangiopathies Diabetic Nephropathy Diabetic Retinopathy Diagnosis Diagnostic Dietary intake Disease Disease Outcome Disease regression Distal Dropout Dyslipidemias Economic Models Economics Effectiveness Effectiveness of Interventions Electrocardiogram End Point Enrollment Epidemiologic Studies Epidemiology Erythrocytes Ethnic Origin Evaluation Event Evolution Excretory function Exercise Exposure to Failure Fasting Fibrinogen Follow-Up Studies Frequencies Functional disorder Funding Fundus Fundus photography Gender General Population Gills Glucose Glucose Intolerance Glucose tolerance test Goals Grant Graph Group Meetings Hazard Controls Health Health Benefit Health Care Costs Health Personnel Health Professional Healthcare Heart Diseases Hemoglobin Hemostatic Agents Heterogeneity High Blood Pressure High Density Lipoprotein Cholesterol High Pressure Liquid Chromatography High Prevalence Hip region structure Hispanics Homocysteine Homocystine Hour Hyperglycemia Hyperlipidemia Hypertension Hypotension Incidence Individual Institutes Insulin Insulin Resistance Insulin-Like Growth Factor I Intake Intention Intervention Invasive Investigation Kidney Kidney Diseases Knowledge LDL Cholesterol Lipoproteins Laboratories Left Life Life Style Life Table Analyses Life Table Estimate Life Table Method Life Tables Light Linear Models Link Lipids Lipoproteins Living Costs Logistic Models Long-Term Effects Longitudinal Studies Low-Level Laser Therapy Masks Matched-Pair Analysis Measurement Measures Medial Medical History Medicine Mental Depression Metabolic Metformin Methods Michigan Microalbuminuria Microaneurysm Mind Minority Modeling Modification Monitor Morbidity - disease rate Multicenter Studies Myocardial Infarction National Eye Institute National Health and Nutrition Examination Survey National Institute of Diabetes and Digestive and Kidney Diseases Natural History Nature Neurologic Neuropathy Newly Diagnosed Non-Insulin-Dependent Diabetes Mellitus Not Hispanic or Latino Numbers Nutrient OGTT Obesity Observational Study Ophthalmologist Organ Other Finding Outcome Outcome Measure Paired Comparison Paper Participant Particle Size Pathogenesis Patients Peripheral Nervous System Diseases Personal Satisfaction Persons Pharmaceutical Preparations Phase Photography Physical Examination Physical activity Pima Indian Placebos Plasma Plasminogen Activator Inhibitor 1 Play Population Population Study Populations at Risk Pre-study Predisposition Premenopause Prevalence Prevention Primary Prevention Principal Investigator Procedures Process Process Measure Prospective Studies Proteins Protocols documentation Psychological reinforcement Public Health Purpose Quality of life Questionnaires Race Random Allocation Randomized Range Rate Reading Recording of previous events Reflex action Relative (related person)Relative Risks Reporting Research Research Design Research Personnel Research Training Resistance Resources Retinal Diseases Risk Risk Estimate Risk Factors Risk Reduction Role SF-36 Sample Size Sampling Scanning Schedule Screening procedure Selection Bias Self-Administered Side Significance Level Sodium Chloride Specific qualifier value Spottings Staging Standards of Weights and Measures Statistically Significant Stratification Stroke Subgroup Suggestion Surveys Symptoms TNF gene Techniques Test Result Testing Thiazolidinediones Thick Thinking Ticks Time Tissues Touch sensation Translating Translations Treatment Effectiveness Triglycerides Ultrasonography United States Public Health Service Universities Upper arm Uric Acid Urine Vascular Diseases Visit Visual Week Weight Wisconsin Woman World Health Organization adjudicate base cardiovascular disorder risk cardiovascular risk factor clinical Diagnosis cohort comparison group cost cost effectiveness cysteine rich protein demographics design diabetes prevention program diabetes risk diabetic early onset epidemiology study experience follow-up glucose tolerance glycation hazard illness length impaired glucose tolerance improved indexing insight instrument interest intervention program life time cost lifestyle intervention member men mortality non-diabetic oral glucose tolerance pre-clinical prevent prognostic programs prospective racial and ethnic sex size stereoscopic tool treatment duration treatment effect type I diabetic urinary volunteer

项目摘要

DESCRIPTION (provided by applicant): The Diabetes Prevention Program is a multicenter controlled clinical trial examining the efficacy of an intensive life-style intervention or metformin to prevent or delay the development of diabetes in a population selected to be at high risk due to the presence of impaired glucose tolerance (IGT). Development of diabetes, defined by 1997 ADA criteria, is the primary outcome while cardiovascular disease and its risk factors are important secondary outcomes. The DPP began recruitment in mid-1996. At the time of this application, total study exposure is a mean of approximately 3 years (range 2 to 5) with a total of approximately 10,000 patient years in the 3,234 volunteers in the 3-arm study. On the basis of a statistically significant and clinically compelling decrease in the development of diabetes in the life-style intervention and metformin-treated groups (58% and 31% reductions, respectively) compared with the placebo treated group, the DPP Data Monitoring Board and NIDDK ended the masked treatment phase of the study in May, 2001, one year earlier than originally planned. This application is designed to take further advantage of the scientifically and clinically valuable cohort of DPP volunteers and the large volume of data collected during the study. The highly compliant DPP cohort, including 45% minorities, is the largest IGT population ever studied. Moreover, the subcohort that has developed diabetes (n approximately 700) has been followed from near the exact time of diabetes onset. Clinically important research questions remain in the wake of the DPP. The carefully collected, centrally measured and graded data in this cohort should help to answer, definitively, a number of important questions regarding the clinical course of IGT and early onset type 2 diabetes. Specific aims include: 1. Examine the long-term effects and durability of prior DPP intervention on the major DPP outcomes including diabetes, clinical cardiovascular disease, atherosclerosis, CVD risk factors, quality of life and cost-benefit; 2. Determine the clinical course of new onset type 2 diabetes and IGT, in particular regarding microvascular and neurologic complications; 3. Determine the incidence of cardiovascular disease (CVD), CVD risk factors and atherosclerosis in new onset type 2 diabetes and IGT; and 4. Examine topics 1-3 in minority populations, men vs. women, and in older subjects in the DPP. The current application is for 5 years of funding, although the some of the goals of the projects described will require a 10-year study.

描述（由申请人提供）：糖尿病预防计划是一项多中心对照临床试验检查强化生命式干预或二甲双胍的功效预防或延迟被选为所在的人群中糖尿病的发展由于存在葡萄糖耐受性受损（IGT）而引起的高风险。发展由1997年ADA标准定义的糖尿病是主要结果心血管疾病及其危险因素是重要的次要结果。 DPP于1996年中开始招募。在此申请时，总计研究暴露是大约3年（范围2至5），总计在3臂的3234名志愿者中约有10,000年的患者年份学习。基于统计学意义和临床引人注目减少生命式干预中糖尿病的发展和二甲双胍处理的组（分别降低58％和31％）安慰剂治疗组，DPP数据监视委员会和NIDDK结束了 2001年5月，研究阶段的掩盖治疗阶段比最初计划。该应用程序旨在进一步利用科学的优势以及临床上有价值的DPP志愿者和大量数据的队列在研究期间收集。高度合规的DPP队列，包括45％少数民族是有史以来最大的IGT人群。此外，子幼虫从附近遵循的糖尿病已经发生了糖尿病发作的确切时间。临床上重要的研究问题留在DPP之后。精心收集，中央测量和该队列中的分级数据应有助于回答许多有关IGT和早期发作2的临床过程的重要问题糖尿病。具体目的包括：1。检查长期影响和对主要DPP结果的事先DPP干预的耐用性糖尿病，临床心血管疾病，动脉粥样硬化，CVD风险因素，生活质量和成本效益； 2。确定新发作的临床过程 2型糖尿病和IGT，特别是关于微血管和神经系统的并发症； 3。确定心血管疾病（CVD），CVD的发生率新发作2型糖尿病和IGT的危险因素和动脉粥样硬化；和4。在少数族裔，男人与女性和年龄较大的人群中检查主题1-3 DPP中的受试者。当前的申请是5年的资金，尽管所述项目的某些目标将需要10年学习。